[Federal Register Volume 62, Number 151 (Wednesday, August 6, 1997)]
[Notices]
[Pages 42256-42257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20633]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0309]
Agency Information Collection Activities: Proposed Collection;
Extension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
regarding the manufacture of infant formula, including infant formula
labeling, quality control procedures, notification requirements, and
recordkeeping.
DATES: Submit written comments on the collection of information by
October 6, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1223.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
[[Page 42257]]
or requirements that members of the public submit reports, keep
records, or provide information to a third party. Section 3506(c)(2)(A)
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to
provide a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
of an existing collection of information, before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information listed
below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Infant Formula Requirements (21 CFR 106.100, 21 CFR 106.120(b), 21
CFR 107.10(a), 21 CFR 107.20, 21 CFR 107.50(e)(2), 21 CFR
107.50(b)(3), 21 CFR 107.50(b)(4), 21 CFR 107.50(c)(3))--(OMB
Control Number 0910-0256)--Extension
Statutory requirements for infant formula under the Federal Food,
Drug, and Cosmetic Act (the act) are strict to protect the health of
infants and include a number of reporting and recordkeeping
requirements. Among other things, section 412 of the act (21 U.S.C.
350a) requires manufacturers of infant formula to establish and adhere
to quality control procedures, notify FDA when a batch of infant
formula that has left the manufacturer's control may be adulterated or
misbranded, and keep records of distribution. FDA has issued
regulations to implement the act's requirements for infant formula in
21 CFR parts 106 and 107.
FDA also regulates the labeling of infant formula under the
authority of section 403 (21 U.S.C. 343). Under the labeling
regulations for infant formula in 21 CFR part 107, the label of an
infant formula must include nutrient information and directions for
use. The purpose of these labeling requirements is to ensure that
consumers have the information they need to prepare and use infant
formula appropriately.
In a notice published in the Federal Register of July 9, 1996 (61
FR 36154), FDA proposed changes in the infant formula regulations,
including some of those listed below. The notice included revised
burden estimates for the proposed changes and solicited public comment.
In the interim, however, FDA is seeking an extension of OMB approval
for the current regulations so that it can continue to collect
information while the proposal is pending.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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106.120(b) 4 7 28 10 280
107.10(a)
107.20
107.50(b)(3),(b)(4) 3 4 12 5 60
107.50(e)(2)
Total 340
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There are no capital costs or operating and maintenance costs associated with this collection.
Table 2.--Estimated Annual Recordkeeping Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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106.100 4 10 40 7,980 31,920
107.50(c)(3)
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There are no capital costs or operating and maintenance costs associated with this collection.
In compiling these estimates, FDA consulted its records of the
number of infant formula submissions received in the past. The figures
for hours per response are based on estimates from experienced persons
in the agency and in industry. Because these infant formula regulations
implement statutory information collection requirements, only the
additional burden attributable to the regulations has been included in
the estimates.
Dated: July 30, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20633 Filed 8-5-97; 8:45 am]
BILLING CODE 4160-01-Fst